Eleventh Circuit Sets Aside FDA Marketing Denial Letters Issued to Six E-Cigarette Companies

On Tuesday, the Eleventh Circuit Court of Appeals issued an opinion setting aside marketing denial orders issued to six electronic cigarette companies by the Food and Drug Administration (FDA). 

According to the opinion, the petitioners, Bidi Vapor LLC, Diamond Vapor LLC, Johnny Copper, LLC, Vapor Unlimited LLC, Union Street Brands LLC and Pop Vapor Co. LLC, are tobacco companies that manufacture electronic nicotine-delivery system products who applied for premarket authorization by the FDA before September 2020. 

The court states that the Tobacco Control Act of 2009 prohibits manufacturers from selling new tobacco products without approval by the FDA. Further, in 2016, the FDA ruled that electronic nicotine-delivery systems, such as e-cigarettes, were tobacco products under the FDA’s regulatory authority. After the ruling, the FDA set a September 9, 2020 deadline for manufacturers to apply for premarket authorization to be approved to sell electronic nicotine-delivery systems.

Under the Tobacco Control Act, the FDA is required to deny applications if it determines that marketing the products would not be appropriate for the protection of public health. Before the September 2020 deadline, the FDA issued guidance and held meetings to explain to manufacturers what evidence would be required in their applications to be approved. The court states that the FDA repeatedly informed companies that marketing and sales-access-restriction plans were relevant to its determination of whether their products were “appropriate for the protection of the public health.”

The opinion states that the six petitioners received almost identical marketing denial orders from the FDA for their non-tobacco-flavored products explaining that the companies failed to demonstrate that their flavored products will provide a benefit to adult users that would be adequate to outweigh the risks to youth. Following the orders, each of the companies filed petitions for review which the court consolidated for the present decision. 

In the opinion, the court states that the FDA improperly failed to consider the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access. Further, it states that the FDA argued that it did not need to consider the sales-access-restriction plans due to its need to efficiently review applications and its experience that sales-access-restrictions do not sufficiently reduce youth use of electronic cigarettes. 

However, the court held that the sales-access-restriction plans were a relevant factor that should have been considered by the FDA making their marketing denial orders arbitrary and capricious because agencies must consider relevant factors when issuing a decision. Therefore, the court set aside the marketing denial orders and remanded the cases to the FDA. The petitioners are represented by Thompson Hine LLP and the Najvar Law Firm.